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BIO 2006 aftermath and a taste of bio-generics

One of my favorite Rolling Stones' albums, not necessarily their best mind you, growing up was "Aftermath", an appropriate label for this period following all the intensity and excitement of BIO 2006- Chicago.

As BIO 2006 - Chicago is still fresh in our minds, I was going to give my take on the outcome, but so many others have already done so that I will wai......

Full article >>> addressed the worldwide generic pharmaceutical market. The reality is that the generic market differs widely around the world due to the role of patents, physician compensation, patient insurance reimbursement, and other factors in each country.

In places like India where patents are just beginning to take effect, prices are among the lowest in the world but will gradually rise. On the ot......

Full article >>> r patents expire (or have already expired some time ago), and a number of companies have lined up to both produce and launch these products in Europe and the United States, but the regulatory authorities in both regions have put the brakes on any approval process.

Traditionally, generics have been able to get FDA approval through a relatively simple Abbreviated New Drug Approval (ANDA) pr......

Full article >>> CompanyActive DrugPatent Expiration DateGlobal Sales(2002)HumulinEli LillyHuman insulin2001$1.0 billionIntron ASchering-PloughAlpha-interferon2002$2.5 billionProcritAmgen/J&Jerythropoietin<......

Full article >>> as been incredible jockeying for worldwide position in the generic market by several major players:

1. Teva Pharmaceuticals - Headquartered outside of Tel Aviz, Israel, ratcheted up its worldwide presence by the acquisition of fellow generic company IVAX last year and Sicor the year before.

2. Sandoz Pharmaceuticals (a division of pharmaceutical mega-player Novartis......

Full article >>> -Hetero Drugs-Hikal--IPCA Labs-Jal Limited--Krebs Biochemicals--Lupin-Malladi Drugs--......

Full article >>> you know that this is heating up, Sandoz filed a lawsuit against the FDA in September, 2005 regarding non-approval of its human growth hormone product.

The issue the FDA is grappling with is a need to show greater safety with these products requiring companies to do more clinical trials for bio-generics. It appears that a physician prescription will also be coupled with dispensing of the......

Full article >>> member of the Illinois Biotechnology Industry Organization. He can be reached at rosenmichaels@aol.com

The opinions expressed herein or statements made in the above column are solely those of the author and do not necessarily reflect the views of The Wisconsin Technology Network, LLC. (WTN). WTN, LLC, accepts n......

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Source:wistechnology.com By Michael Rosen 04/23/06


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